Strategic Treatment Reduction in Very Early Liver Disease With 4 Weeks Sofosbuvir Plus Glecepravir-pibrentasvir

Ki vehet részt

• Participants must meet all inclusion criteria to be eligible to participate in this study:
• Have voluntarily signed the informed consent form
• 18 years of age or older
• Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months
• Quantifiable HCV RNA at screening
• HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication)
• Liver fibrosis stage F0-F2, defined by at least one of the following:; Liver stiffness measurement <9.5 kPa by transient elastography (FibroScan®); AST to platelet ratio index (APRI) <0.5; Liver biopsy
• If co-infection with HIV is documented, the subject must meet the following criteria:; ART naïve with CD4 T cell count >500 cells/mm3; OR; On a stable ART regimen (containing only permissible ART - see protocol section 6.3) for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and a plasma HIV RNA level below the limit of detection
• Negative pregnancy test at screening and baseline (females of childbearing potential only)
• All fertile females must be using effective contraception during treatment and during the 30 days after treatment end

Ki nem vehet részt

• Participants who meet any of the exclusion criteria are not to be enrolled in this study; History of any of the following:; Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded; Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage); Solid organ transplant; History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs; Any of the following lab parameters at screening:; ALT > 10 x ULN; AST > 10 x ULN; Direct bilirubin > ULN; Platelets < 150,000/μL (cells/mm3); Creatinine clearance (CLcr) < 50 mL/min; Albumin < LLN; INR > 1.5 ULN; Pregnant or breastfeeding female; HBV infection (HBsAg positive); Use of prohibited concomitant medications as described in protocol section 6.3; Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks); Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months prior to the first dose of study drug; Any investigational drug ≤6 weeks prior to the first dose of study drug; Ongoing severe psychiatric disease as judged by the treating physician; Inability or unwillingness to provide informed consent or abide by the requirements of the study